a study of dulaglutide (ly2189265) in participants with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the main purpose of this study is to evaluate the efficacy and safety of the study drug known as dulaglutide when added to sodium-glucose co-transporter 2 (sglt2) inhibitors in participants with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes mellitus (based on the world health organization's \[who\] diagnostic criteria) * have been treated with an sglt2 inhibitor, with or without metformin, for at least 3 months prior to study entry (minimum required doses for that period for allowed sglt2 inhibitors: empagliflozin 10 mg, dapagliflozin 5 or 10 mg \[per country-specific label\], canagliflozin 100 mg); minimum required dose for metformin, if used, is ≥1500 mg/day and must be reached (or highest tolerated dose which is acceptable with documented gastrointestinal \[gi\] intolerability) * daily doses of all allowed oral antihyperglycemia agent (oams) must have been stable for at least 12 weeks (±3 days) prior to randomization (study enrollment); daily doses of sglt2 inhibitor and metformin, if used, will be considered stable during this period if: * all prescribed daily doses were in the range between the minimum required dose and maximum-approved dose per country-specific label; and * \>90% of prescribed daily doses were equal to the dose at randomization * have hba1c ≥7.0% and ≤9.5% at study entry and approximately 1 week prior to randomization * have body mass index (bmi) ≤45 kilograms per meter squared (kg/m\^2) and agree to not initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment exclusion criteria: * have type 1 diabetes mellitus * have been treated with any other oams (other than sglt2 inhibitors and metformin), glucagon-like peptide-1 receptor agonist (glp-1 ra), pramlintide or insulin 3 months prior to study entry, or between study entry and randomization; or initiate metformin between study entry and randomization; short-term use of insulin for acute care (≤14 days) during the 3-month period prior to entry is not exclusionary * have any condition that is a contraindication for use of the glp-1 ra class or the sglt2 inhibitor class (per country-specific labels) at study entry or develop such condition between study entry and randomization * have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (nafld), or alanine transaminase (alt) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with nafld are eligible for participation in this trial * had chronic or acute pancreatitis any time prior to study entry * estimated glomerular filtration rate (egfr) \<45 milliliters(ml)/minute/1.73m\^2, calculated by the chronic kidney disease-epidemiology (ckd-epi) equation, as determined by the central laboratory at study entry and confirmed at lead in * have any self or family history of type 2a or type 2b multiple endocrine neoplasia (men 2a or 2b) in the absence of known c-cell hyperplasia (this exclusion includes participants with a family history of men 2a or 2b, whose family history for the syndrome is rearranged during transfect \[ret\]-negative; the only exception for this exclusion will be for participants whose family members with men 2a or 2b have a known ret mutation and the potential participant for the study is negative for the ret mutation) * have any self or family history of medullary c-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial, or part of men 2a or 2b syndrome) * have a serum calcitonin ≥20 picograms/ml as determined by the central laboratory at study entry